Job opening: Health Science Specialist - Regulatory Specialist (Biospecimens)
Salary: $103 409 - 167 336 per year
Published at: Aug 07 2024
Employment Type: Full-time
The position is located in the Office of Research and Development, Veterans Health Administration and will be responsible for serving as the regulatory expert and consultant on policies, procedures, guidance, and FAQs related to biospecimens in VA conducted research studies.
This vacancy may be filled in Washington, DC or a VA location to be determined.
This announcement will close on 8/13/24 or at 11:59PM EST on the date 100 applicants are received, whichever is first.
Duties
Consults on policies, procedures, guidance, and FAQs related to biospecimens in VA conducted research studies.
Reviews, revises, and coordinates publishing research policies, guidance documents, and FAQs related to biospecimens.
Oversees all aspects of the program, including committing resources, gaining compliance with policies and procedures, and resolving complex issues.
Develops policy and oversees human biospecimens, including blood and other body fluids, tissues, and other biological materials obtained from humans.
Develops policy related to subsets of human materials, such as derived cell lines that are traceable to a human subject or patients with linked identifiers or Personally Identifiable Information (PII), as well as those materials that cannot be linked to identifiers.
Serves an as expert consultant to the VA ORD funded biorepository programs.
Possess knowledge in legal and ethical considerations related to biospecimen donation, collections, processing, handling, storage, inventory tracking, quality management practices, custodianship, disposal, sharing, release, and shipping.
Provides education and training to the research staff, medical center staff, investigators, and their study staff, on biospecimen policies and procedures.
Responds to emails related to biospecimen policy and questions from the field investigators, program offices and research staffs.
Develops tools and provide education for the research program office and research programs related to biospecimen issues to assist in regulatory compliance.
Participates in field visits to audit biospecimen facilities/collections and review local policies in anticipation of federal oversight visits.
Reviews audit reports from federal agencies for potential correctable issues related to biospecimen collection and maintenance.
Work Schedule: Monday through Friday, 8:00 am to 4:30 pm
Telework: Available VA supports the use of telework as a way to help attract and retain talented individuals in public service, increase worker productivity, and better prepare the agency to operate during emergencies. This position may be authorized for telework. Telework eligibility will be discussed during the interview process.(applicant is required on site 50% of work schedule per pay period)
Remote: This is not a remote position.
Virtual: The employee may work at a VA facility or other VA-leased space other than the facility that is hiring the employee and is authorized for telework up to 50%.
Relocation/Recruitment Incentives: Not authorized
Critical Skills Incentive (CSI): Not approved
Financial Disclosure Report: Not required
Qualifications
To qualify for this position, applicants must meet all requirements by the closing date of this announcement.
Education Requirement: You must possess a bachelor's degree (or higher) from an accredited college or university with a major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of this a Health Science Specialist -Note: Transcript(s) must be submitted at the time of application. Please ensure that your transcripts show that a degree was conferred in the appropriate field. Unofficial transcripts are acceptable
.~ AND ~
Specialized Experience Requirement: You must ALSO have one year of specialized experience equivalent to at least the next lower grade GS 12 in the normal line of progression for the occupation in the organization. Examples of specialized experience is: Providing program management in a research setting of a biospecimens program; Providing technical advice and guidance regarding biospecimens to managers and researchers; Developing policies, procedures, and criteria for administration of a biospecimens program.
You will be rated on the following Competencies as part of the assessment questionnaire for this position:
Audit ReportingStandardsTeaching OthersTechnical Competence
IMPORTANT: A full year of work is considered to be 35-40 hours of work per week. All experience listed on your resume must include the month and year start/end dates. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment.
Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.
Physical Requirements: The work is primarily sedentary, including typical office work. The work does include travel to biospecimen handing facilities, meetings, and conferences.
For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/.
Education
There is no educational substitution for the one year of specialized experience at this grade level.
NOTE: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here:
http://ope.ed.gov/accreditation/. If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit:
Recognition of Foreign Qualifications | International Affairs Office (ed.gov).
Contacts
- Address VSHO - Discovery, Education and Affiliate Networks
2402 Wildwood Ave Suite 301
Sherwood, AR 72120
US
- Name: VHA National Recruitment Center
- Phone: (844)456-5208
- Email: [email protected]